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FDA 510(k)

BIOFIX* BIODEGRADABLE FIXATION ROD

K-Number: K890902 · 1989-11-03

ApplicantDavis & Geck, Inc.
Decision Date1989-11-03
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFIX* BIODEGRADABLE FIXATION ROD is the device name listed in this FDA 510(k) record. The listed applicant is Davis & Geck, Inc.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K890902. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIX* BIODEGRADABLE FIXATION ROD?

BIOFIX* BIODEGRADABLE FIXATION ROD is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K890902.

When did BIOFIX* BIODEGRADABLE FIXATION ROD receive FDA 510(k) clearance?

BIOFIX* BIODEGRADABLE FIXATION ROD received FDA 510(k) clearance on 1989-11-03, under 510(k) number K890902.

Who is the listed applicant for BIOFIX* BIODEGRADABLE FIXATION ROD?

The FDA 510(k) record lists Davis & Geck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOFIX* BIODEGRADABLE FIXATION ROD?

The FDA product code for BIOFIX* BIODEGRADABLE FIXATION ROD is HTY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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